Evaluation of Nutrition Bio-Shield (NBS) herbal supplement effects on the recovery of patients with multi-drug resistant tuberculosis
Design
A controlled, parallel-group, double-blind, by random block method, phase 3 clinical trial on 88 patients.
Settings and conduct
In this study patients and researchers don't know which group of patients will use the Nutrition Bio-Shield (NBS). This clinical trial will be conducted in Imam Khomeini Hospital in Tehran. The intervention group (n=44), in addition to receiving the routine antibiotic panel adopted by the attending physician based on the guidelines, will also receive NBS powder for 6 months. The control group (n=44) also receives the same antibiotic panel along with placebo. Before and after the intervention, the demographic and laboratory parameters considered in this study are collected from the patients and recorded in the file. Finally, our data will be analyzed by significant statistical methods.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with multi-drug resistant tuberculosis ; Patients over 18 years old
Exclusion criteria:
Patient's refusal to continue the study ; Patients suffering from any other chronic disease such as diabetes, cardiovascular disease, etc. ; Pregnant and lactating mothers ; Use of corticosteroids and immunosuppressive drugs ; Observing any drug sensitivity as diagnosed by the attending physician ; Patient's death
Intervention groups
NBS (Nutrition Bio-Shield) powder will be prescribed to the intervention group, 4.5 grams daily in three doses of 1.5 grams for 6 months along with antibiotic treatment. In addition to the antibiotic panel, the control group will also receive a placebo.
Main outcome variables
Age ; Sex ; Duration of infection ; Microbial load ; Death ; Count of white blood cells ; CRP ; ESR ; Hospitalization period
General information
Reason for update
Acronym
NBS-TB
IRCT registration information
IRCT registration number:IRCT20230116057135N1
Registration date:2023-01-21, 1401/11/01
Registration timing:prospective
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Mehrdad Mosadegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 563 3390
Email address
m-mosadegh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of NBS herbal powder effects as a complementary medicine on the recovery of patients with multi-drug resistant tuberculosis
Public title
The effect of NBS powder in treatment of patients with multi-drug resistant tuberculosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with multi-drug resistant tuberculosis
Patients over 18 years old
Exclusion criteria:
The patient's withdrawal from the study
Patients with any other chronic disease such as diabetes, cardiovascular disease, etc.
Patients who have received supplements of vitamin D, zinc, B vitamins and other micronutrients in the last month.
Patients who do not come for follow-up treatment at specified intervals
Pregnant and lactating mothers
Use of corticosteroids and immunosuppressive drugs
Observing any drug sensitivity (especially digestive sensitivity to gluten) as determined by the attending physician
Deterioration of the patient's clinical symptoms due to the consumption of Nutrition Bio-Shield (NBS) powder, as determined by the attending physician
Patient's death during common and selective treatments (in case of death, the patient's information is fully recorded and laboratory tests are performed along with other samples to determine the possible effect of the drug on the patient's death)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into intervention and control groups by random block method. Allocation of the samples to two groups with random permutation block design will be two treatments with blocks of four. In this way, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the alternating combinations of the letters A, A, B, and B, which are 6 different combinations, on 6 cards in this order: AABB, ABBA, ABAB, BAAB, BABA, BBAA, then a digit is randomly selected from 1 to 6. and continue this process until the sample volume reaches the quorum.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients and researchers don't know which group of patients will use the Nutrition Bio-Shield (NBS). Physician and clinicians team know about the group who use the powder.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina St., Qods St., Enghelab St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
IR.TUMS.SPH.REC.1401.206
Health conditions studied
1
Description of health condition studied
Respiratory tuberculosis
ICD-10 code
A15
ICD-10 code description
Respiratory tuberculosis
Primary outcomes
1
Description
Microbial load
Timepoint
Before of the intervention, monthly monitoring, after of the intervention
Method of measurement
Examining the Ziehl–Neelsen staining slide, colony count
2
Description
Measurement of white blood cells
Timepoint
Before of the intervention, After of the intervention
Method of measurement
Cell Counter
3
Description
Measurement of inflammatory factors
Timepoint
Before of the intervention, After of the intervention
Method of measurement
Gold Standard Methods (Westergren method for ESR, Electrochemical Immunoassay for CRP)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in intervention group in addition to the standard antibiotic treatment regimen + Nutrition Bio-Shield (NBS) powder will be prescribe is below: Dosage of NBS is 500 mg capsules daily in 4.5 grams given in divided doses of 1.5 gram in the morning, 1.5 gram in the noon and 1.5 gram in the night for 6 months.
Category
Treatment - Drugs
2
Description
Control group: Patients in intervention group in addition to the standard antibiotic treatment regimen + Placebo capsules given in the morning, noon and night.